Kornimate/medical-research-clean huggingface dataset:
effects of estrogen on memory in post-menopausal women and patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate alzheimer's disease will enhance their memory and their capacity for learning.

estrogen (est) may have significant benefits in preserving cognitive functioning in normal aging after menopause and in decreasing the incidence of alzheimer's disease (ad). on a molecular level, est has effects on a variety of cholinergic neuronal and receptor-mediated mechanisms that may be responsible for these beneficial effects. these neurons have critical relevance for the development of age-related cognitive changes and dementing disorders. however, little is known about the clinical relevance of est-cholinergic interactions, either in normal aging or in ad. the primary goal of this study is to test the hypothesis that three months of administration of est to 1) normal post-menopausal women, and 2) female patients with mild-moderate ad who are concurrently treated with anticholinesterase therapy (donepezil), will positively change or blunt the negative and behavioral effects of drugs that block central cholinergic receptors (both muscarinic and nicotinic). participants will be blindly placed on est or placebo for three months each. after each three month period, they will be cognitively assessed after receiving single doses of the cholinergic antagonists scopolamine and mecamylamine. these results will have direct implications for the use of est in post-menopausal women as well as interactive treatment with cholinergic drugs for ad. researchers plan to recruit a total of 45 women (30 healthy, and 15 patients with ad). note: this study is only recruiting participants with alzheimer's disease at this time.

Eligibility criteria:
inclusion criteria: * normal volunteers and women with mild alzheimer's disease: * non-smoker * no use of hormone replacement therapy for at least one year * no menses for at least one year * normal mammogram within the last year * minimum age is 45 for patients with alzheimer's disease; 50 for normal volunteers * maximum age is 85 for patients with alzheimer's disease; there is no maximum age for normal volunteers. exclusion criteria: * women who are currently taking estrogen therapy. * women who are smokers. * women who have had breast cancer.

Keywords: alzheimer disease estrogen therapy post-menopausal women
indicators of growth, nutritional status and comorbide disorders of newborns with down syndrome

Conditions: Down Syndrome,Auxological Indexes, Auxological Parametars, Intrauterine Growth Restriction

Summary: objective to access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with down syndrome (ds) study design in this cohort retrospective study, 141 newborns with proven trisomy 21 born at the department of gynecology and obstetrics of the university of split hospital (1990 to 2015) were included. the data were obtained from the medical histories of mothers, infants and the delivery protocol. the objective was to access predictive values of the auxological parameters and indexes for risk of comorbid malformations in newborns with down syndrome (ds) conclusion higher ci were found in hyportrophic (sga) newborns with ds and indicated their intrauterine growth restriction with brain sparing and increased further risk of severe psychomotor retardation. the sga newborns have lower parameters and indexes of nutritive status and significantly differed from eutrophic and hypertrophic newborns. these sga newborns with ds have increased developmental risks and that requires further diagnostic attention.

use of anthropometric charts developed specifically for children with ds have a better expression of real growth restriction (small for gestation age/sga, 9.9%) than the application of the percentile curve for typical children (sga, 24.1%). these differences were also noted in the evaluation of other anthropometric measures. cephalization index (ci) proved to be the only predictor from the considered auxological parameters and indexes with minimal predictive value in the prediction of heart defects type asd ii and vsd. the presence of comorbid disorders in newborns with ds did not have a significant predictive role on growth indicators and nutritive status of the newborn, but we noted a strong association between preterm births and white matter injury (wmi).

Eligibility criteria:
inclusion criteria: the study included newborns with proven trisomy 21 born at the department of gynecology and obstetrics of the university of split hospital center from 1990 to 2015 exclusion criteria: * excluded newborns with proven trisomy 21 died at first week of life

Keywords: growth restriction, nutritive status, comorbide disorders, down syndrome
phase i/ii study of srp-4053 in dmd patients

Conditions: Duchenne Muscular Dystrophy

Summary: this is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of srp-4053 in duchenne muscular dystrophy (dmd) patients with deletions amenable to exon 53 skipping.

part 1: randomized, placebo-controlled dose-titration to assess safety, tolerability and pharmacokinetics of 4 dose levels of srp-4053 in genotypically-confirmed dmd patients with deletions amenable to exon 53 skipping. part 2: open-label evaluation of srp-4053 in patients from part 1, along with newly enrolled dmd patients with deletions amenable to exon 53 skipping and an untreated group of dmd patients with deletions not amenable to exon 53 skipping. safety, including adverse event monitoring and routine laboratory assessments, will be followed on an ongoing basis for all patients. clinical efficacy, including functional tests such as the six-minute walk test (6mwt), will be assessed at regularly scheduled study visits. patients in the treated groups will undergo one baseline and one follow-up muscle biopsy. patients in the untreated group will not undergo biopsies and will follow an abbreviated schedule of study assessments.

Eligibility criteria:
inclusion criteria: * diagnosed with dmd, genotypically confirmed. * intact right and left biceps muscles or an alternative upper arm muscle group. * stable pulmonary and cardiac function. * minimum performance on 6mwt, north star ambulatory assessment, and rise (gowers) test as specified in the study protocol. * on a stable dose of corticosteroids for at least 6 months. exclusion criteria: * previous treatment with the experimental agents bmn-195 (smt c1100) or pro053. * current or previous treatment with any other experimental treatments within 12 weeks prior to study entry. * major surgery within the last 3 months. * presence of other clinically significant illness. * major change in physical therapy regime within the last 3 months. other inclusion and exclusion criteria may apply.

Keywords: duchenne muscular dystrophy exon skipping dmd exon 53 ambulatory pediatric
assessment of autogenous dentin graft in treatment of infra-bony defect

Conditions: Periodontitis (Stage 3)

Summary: the aim of the present study was to evaluate the effect of demineralized autogenous dentine on treatment of infrabony defects.

in this study, the investigators tested the effect of demineralized autogenous dentine as a bone graft in treatment of stage iii periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and bone gain in defect sites.

Eligibility criteria:
inclusion criteria: * patients with good systemic health and no contraindication for periodontal surgery. * patients who are able to maintain good oral hygiene. * gingival thickness for the site selected should be ≥1mm. * probing depth of ≥ 6mm. * patient has at least one hopeless teeth exclusion criteria: * active infectious diseases (hepatitis, tubercu¬losis, hiv, etc....). * medically compromised patients. * smokers and alcoholic abusers * people who suffer from any systemic disease that affect the periodontium. * pregnant, postmenopausal women. * people who take anti-inflammatory drugs, anti¬biotics or vitamins within the previous 3 month. * people who use mouth washes regularly * participants in other clinical trials.
effect of at-derived mirna on the biology and insulin sensitivity of skeletal muscle in humans

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is examine the effect of fat tissue-released mirna on skeletal muscle and if abnormal fat tissue-released mirna contributes to insulin resistance in obese individuals. this information will be important for our understanding of how the body's sugar metabolism is regulated and why people who are obese become insulin resistant and are more likely to develop type 2 diabetes.

study objectives: 1. to establish and optimize the methodology for measuring adipose tissue mirna release. 2. to establish and optimize the methodology for measuring the effect of adipose tissue-released mirna on skeletal muscle biology and insulin sensitivity. 3. to profile adipose tissue-released mirna in lean insulin-sensitive and obese insulin-resistant healthy individuals. 4. to examine the effects of adipose tissue-released mirna from lean insulin-sensitive individuals and obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity.

Eligibility criteria:
inclusion criteria: * able to communicate meaningfully with the investigator and legally competent to provide informed written consent * 18-65 years of age * bmi of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects) * stable body weight (\< 3 kg change in the last 8 weeks) * homeostatic model assessment (homa)-insulin resistance \<2.7 if lean; homeostatic model assessment (homa)-insulin resistance ≥2.7 if obese exclusion criteria: * lactation or pregnancy, current and/or within last 6 months, per participant's report * female subjects postmenopausal * cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months) * liver disease (ast or alt(alanine aminotransferase)\>2.5 times the upper limit of normal) * kidney disease (creatinine \>1.6 mg/dl) * anemia (hemoglobin \<12 g/dl in men, \<11 g/dl in women) * thyroid dysfunction (abnormal tsh) * hba1c ≥6.5% * uncontrolled hypertension (systolic bp\>160 mmhg, diastolic bp\>100 mmhg) * history of coagulopathies * history (within the last 5 years) or presence of malignancy, (skin cancers, with the exception of melanoma, may be acceptable) * current or history of drug abuse or alcohol abuse (\>2 drinks/day) * prior treatment (within last 3 months) with systemic glucocorticoids (\>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates * history of hiv, active hepatitis b or c, or tuberculosis (participant reported) * smoke \> 5 cigarettes per day

Keywords: micro-rna insulin resistance
genetics and epigenetics of graves' orbitopathy

Conditions: Graves Ophthalmopathy

Summary: graves' orbitopathy (go) is an autoimmune disease persisting when immunosuppression is achieved. orbital fibroblasts from go patients display peculiar phenotypes even if not exposed to autoimmunity, possibly reflecting genetic or epigenetic mechanisms, to be investigated here. primary cultures of orbital fibroblasts from go and control patients will be established. cell proliferation, release of hyaluronic acid (ha) and ha synthases (has) will be measured. next generation sequencing and gene expression analysis of the whole genome will be performed, as well as global dna methylation assay.

the investigators will establish primary cultures of orbital fibroblasts from orbital adipose tissue samples taken from six go patients who underwent orbital decompressive surgery. normal orbital tissue samples will be collected from six patients undergoing eye surgery for unrelated reasons. cell proliferation and ha will be measured using commercial assays dna and rna will be extracted. has-1, has-2 and has-3 will be measured were assessed by real time-pcr next generation sequencing, gene expression analysis and dna methylation assays will be performed

Eligibility criteria:
inclusion criteria: * diagnosis of graves' orbitopathy * informed consent exclusion criteria: -lack of informed consent
treatment of unilateral posterior cross bite in children

Conditions: Malocclusion; Maxillary Expansion; Pain Children

Summary: rapid maxillary expansion and quad-helix are two well established appliances in dentistry used for posterior cross bite treatment. this study aims to compare this two different appliances in patients in their early mixed dentition, regarding treatment effects of the extra oral soft tissue but also dental and skeletal effects, if the children experience any pain and discomfort during treatment and the study also aims to make a cost minimization analysis. comparison of these different treatments are barely made and no randomized controlled trial is yet published. no study has evaluated the difference of subjective experience during these two treatments. after this study we will know which one of these two appliances are the most effective, regarding cost minimization and treatment result but we are also able to put it in relation to the patients subjective experience


Eligibility criteria:
inclusion criteria: * children in the early mixed dentition * unilateral posterior cross bite including the first permanent molar exclusion criteria: * no ongoing sucking habits * craniofacial syndroms * earlier orthodontic treatments * not able to independently understand and answer the questionnaires
impact of the restriction of sources of gluten in fibromyalgia patients

Conditions: Fibromyalgia

Summary: the aim of this study is to evaluate the impact of gluten-free diets on symptoms and inflammatory markers in individuals with previous diagnosis of fibromyalgia (fm), as well as to identify the presence of non-celiac gluten sensitivity (ncsg) in individuals with fm. patients with fm diagnosis will be kept on a gluten-free diet for a 10 weeks. in the 7th week, they will receive placebo capsules for 7 days and after washout, capsules containing gluten for another 7 days. a questionnaire based on salerno protocol will be applied to evaluate the presence of ncgs in the beginning, 8th week and 10 week.

fibromyalgia (fm) is a chronic and widespread pain condition, usually accompanied by several associated symptoms such as fatigue, sleep disorder, headache, irritable bowel syndrome and mood disorders. recent studies point to the possibility of gluten protein having a role in the development of fm symptoms in a subgroup of patients. fourteen patients with fm diagnosis will be kept on a diet restrict in gluten-free foods for a period 10 weeks. at the 7th week they received rice protein isolate capsules (placebo) for 7 days, followed by a 3-day wash-out and a new challenge with capsules containing 8 g/day of gluten (corresponding to 6,3g gluten protein) for another 7 days. in the initial period, at 8th week (final of placebo period) and after challenge with gluten (10th week), blood will be collected for analysis of inflammatory markers. questionnaires will be carried out to evaluate the quantity and severity of fm symptoms and the impact of fm on daily routine. inflammatory markers (il-1bera, il-6 and il-10) will be evaluated in the blood. in the challenger period (gluten or placebo) questionnaires will be carried out to evaluate the quantity and severity of symptoms related to fibromyalgia and the impact of fibromyalgia on a daily basis. in addition, a questionnaire based on salerno protocol was applied to evaluate the presence of ncgs.

Eligibility criteria:
inclusion criteria: • women between 18 and 65 years of age with prior clinical diagnosis of fm, according to the american college of rheumatology criteria of 2010 exclusion criteria: * subjects diagnosed with positive serology for celiac disease or allergy to wheat * subjects diagnosed with autoimmune diseases * subjects with diseases that are not part of the comorbidities associated with fm and t hat could influence the results of the study * pregnant or lactating women

Keywords: fibromyalgia; non-celiac gluten sensitivity
analysis of expression of nitric oxide syntheses and their functional role in human urothelium

Conditions: Interstitial Cystitis; Bladder Diseases; Urinary Incontinence

Summary: painful bladder syndrome (pbs)/interstitial cystitis (ic) may be due to the actions of nitric oxide (no) in the bladder tissue. no is a gaseous substance with a very short half-life, synthesized by a group of no-synthase-enzymes in many tissues. the goal of this study is to illuminate bladder tissue production of no in individuals with pbs and healthy individuals, by quantification of no and no-enzyme expression by different molecular biological methods.


Eligibility criteria:
inclusion criteria: * pbs/ic according to international continence society (ics) * cystoscopy with bladder distension and deep biopsies within last 5 years * cystometry within last 5 years * normal urine culture within last month inclusion criteria (for control group): * benign non-invasive bladder disease * no pbs/ic * normal urine culture * no functional bladder disease of known nature (ex. infravesical obstruction) exclusion criteria: * age under 18 years * inability to understand instructions * pregnancy and lactation

Keywords: no mrna-expression pathophysiology painful bladder syndrome
acceptability of hiv oral prep among msm and tgw

Conditions: Patient Acceptance of Health Care

Summary: the purpose of this study is to determine the factors associated with acceptability to oral hiv pre-exposure prophylaxis (prep) among thai men who have sex with men (msm) and transgender women (tgw).


Eligibility criteria:
inclusion criteria: * msm or tgw at age18 years or older at enrollment * able to read and write effectively in thai language * negative hiv testing (by assigned rapid tests) at enrollment * available to return for the study visits and willing to comply with study requirements * willing to provide reachable contact numbers and address * creatinine clearance ≥ 60 ml/min * negative urine protein * negative hbs ag exclusion criteria: * symptoms suggestive for acute hiv seroconversion * participating in any interventional hiv research * has any physical or mental condition(s) that, in the opinion of the investigator(s), complicate interpretation of study outcome data

Keywords: oral prep tgw thai msm
detection of early metastases in patients with stage i non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: detecting very early metastases in bone marrow and/or lymph nodes may help doctors plan better treatment for non-small cell lung cancer. purpose: clinical trial to detect the presence of metastatic cancer in patients with stage i non-small cell lung cancer that has not been previously treated.

objectives: * determine whether the presence of occult micrometastases (om) detected by immunohistochemistry or reverse transcriptase-polymerase chain reaction (rt-pcr) in histologically negative lymph nodes or bone marrow is associated with poorer survival among patients with stage i non-small cell lung cancer. * determine the incidence of om in histologically negative lymph nodes and bone marrow by immunohistochemistry (staining for cytokeratins and the cea glycoprotein) or rt-pcr (to detect cea mrna) in these patients. * assess the sensitivity of immunohistochemistry relative to rt-pcr for detecting om in these patients. * determine the relationship between tumor size (or t-stage) and the presence of om detected by immunohistochemistry or rt-pcr in these patients. * determine the relationship between the presence of om and disease-free survival in these patients. * determine the relationship between the site of om and incidence of recurrence, site of recurrence, and survival of these patients. outline: at the time of thoracotomy and pulmonary resection, patients have samples of bone marrow, primary tumor, and intrathoracic lymph nodes harvested. the presence of occult metastases in bone marrow and lymph nodes is assessed using immunohistochemistry or reverse transcriptase-polymerase chain reaction. patients are followed every 6 months for 5 years.

Eligibility criteria:
* clinical stage i proven or suspected new non-small cell lung carcinoma t1 or t2 primary n1 or n2 lymph nodes \<1cm on ct or negative mediastinoscopy * ≥ 5 years since prior chemo or xrt; no prior mediastinal or chest xrt. * ≥ 18 years of age * no history of previous lung cancer or concomitant malignancy

Keywords: stage i non-small cell lung cancer
treating pyelonephritis an urosepsis with pivmecillinam

Conditions: Pyelonephritis; Urinary Tract Infections

Summary: febrile urinary tract infections and urosepsis are common and potentially serious infections that require effective antimicrobial treatment. the duration of parenteral treatment depends on oral alternatives. these alternatives are few and due to antimicrobial resistance, quinolones are "standard of care". the increased use of quinolones is concerning because of its negative ecological aspects and it is confirmed an increasing incidence of resistant e.coli to quinolones in norwegian isolates. pivmecillinam is an antibiotic with high susceptibility to e.coli but the evidence for treating febrile urinary tract infections is insufficient. this trial will investigate the efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by e.coli. the hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given after 2-3 days with empirical i.v. antibiotics.

this trial will be conducted at vestfold hospital, norway, and is a prospective observational study with intention to treat. participants will be consecutively included among hospitalized patients suffering from urosepsis - see eligibility criteria. after 3 days with parenteral antibiotics, when clinical improvement and absence of fever/leukocytosis is confirmed, the participants will start on pivmecillinam 400mg four times daily and be discharged. pivmecillinam is to be taken for one week. the participants will be contacted by phone on day 4, 10 and 33 (days after admission). on day 17 (test of cure, toc) they will meet for physical examination. they will report symptom score (standardized schema) on day 0, and 17. urine samples will be collected on day 10 and 17. blood samples on day 17. all data will be stored anonymously. the trial will be monitored by extern resources.

Eligibility criteria:
inclusion criteria: * e.coli in blood culture * and identical isolate in urine sample (\>= 1.000 cfu) or relevant clinical signs of uti exclusion criteria: * bacterial infection origin from another organ (e.g. pneumonia) * severe sepsis with multiorgan failure * perinephritic abscess * pyonephrosis requiring drainage * allergy to pivmecillinam * e.coli isolate resistant to pivmecillinam * pregnancy/breastfeeding * severe neutropenia * prostatitis * severe kidney failure (egfr\<15 ml/min) * using valproate

Keywords: pivmecillinam